Events

Avis De Sécurité sur Betafine Universal Pen Needles 30G-8mm

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Promisemed Hangzhou Meditech Co. Ltd.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2016-09-29
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    We have received occasional complaints of betafine universal pen needles 30g-8mm with lot number 513061 and have therefore decided to proactively take action and recall this product. sporadically, the steel cannula becomes stuck in the rubber seal of the pen’s insulin cartridge after insulin injection. in such instances, there exists a slight danger of pricking oneself with the already used cannula. the cause has already been established and resolved and therefore we can assure you that only pen needles from lot number513061 can be affected by this issue.

Device

Betafine Universal Pen Needles 30G-8mm

Manufacturer

Promisemed Hangzhou Meditech Co. Ltd